Friday, January 2, 2026 1/2/2026

Early Respiratory Care in Amyotrophic Lateral Sclerosis Patients at High Risk for Respiratory Failure

Award Number: K23HL151879
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 01/01/2021
PERIOD OF PERFORMANCE END DATE: 06/30/2026

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Early Respiratory Care in Amyotrophic Lateral Sclerosis Patients at High Risk for Respiratory Failure - Project Summary/Abstract Respiratory failure commonly occurs in amyotrophic lateral sclerosis (ALS) and leads to significant morbidity and mortality. The onset of respiratory weakness heralds an increased risk of aspiration related to bulbar muscle weakness and ineffective cough, hypercapnic respiratory failure due to chronic hypoventilation, and pulmonary infections, ultimately leading to death. Despite the key role of respiratory failure in the morbidity and mortality associated with ALS, there remains uncertainty concerning optimum initiation and maintenance of respiratory care for this disease. ALS has a very heterogeneous clinical presentation and symptom progression, which causes variable evolution of respiratory involvement. Given the significance of respiratory morbidity with this disease combined with the unclear timing, identifying high-risk subgroups may facilitate studying outcomes of early respiratory interventions. Our group has published a clinical prediction tool which can predict a high risk of respiratory failure within six months in ALS. We have also published a latent class analysis to identify subphenotypes of ALS patients by their differing trajectories of forced vital capacity over time. Applying our clinical prediction tool and knowledge of phenotypes to a sample of ALS patients would identify a subgroup suitable for future clinical trials. However, given the emotional burden of ALS, patient perspectives on respiratory interventions are critical to successful implementation. To our knowledge, a prospective investigation on a cohort of ALS patients at high risk of respiratory failure has yet to be performed. The goals of this study are to use our clinical prediction tool to identify the prevalence of newly-diagnosed ALS patients at high risk of respiratory failure, to elucidate patient perspectives on early respiratory care, and to implement a pilot trial of lung volume recruitment in high-risk patients. This proposal will involve a multicenter study at three academic centers in Philadelphia. We will perform a prospective cohort study of patients with ALS, apply our clinical prediction tool, and monitor them for respiratory failure over one year. We will use semi- structured interviews to gather patient perspectives regarding circumstances under which they would accept early respiratory care in ALS. Third, we will perform a single-arm pilot intervention of lung volume recruitment in newly-diagnosed ALS patients at high risk of respiratory failure within six months. This project will provide essential preliminary data for a Research Project Grant application that will (1) conduct a randomized controlled trial of early respiratory therapy in high-risk ALS patients (2) elucidate physician and caregiver perspectives regarding respiratory care in ALS, and (3) identify which characteristics are associated with different trajectories of respiratory function, thus allowing for personalized medicine.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Lung Diseases Research	000	5	11/18/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $196,458 )
2025	2025	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Lung Diseases Research	000	5	12/20/2024	NON-COMPETING CONTINUATION	$196,458
														Subtotal = $196,458

Issue Date FY: 2024 ( Subtotal = $195,594 )
2024	2024	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Lung Diseases Research	000	4	1/18/2024	NON-COMPETING CONTINUATION	$195,594
														Subtotal = $195,594

Issue Date FY: 2023 ( Subtotal = $196,022 )
2023	2023	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Lung Diseases Research	000	3	1/16/2023	NON-COMPETING CONTINUATION	$196,022
														Subtotal = $196,022

Issue Date FY: 2022 ( Subtotal = $196,884 )
2022	2022	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Lung Diseases Research	000	2	12/18/2021	NON-COMPETING CONTINUATION	$196,884
														Subtotal = $196,884

Issue Date FY: 2021 ( Subtotal = $196,884 )
2021	2021	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Lung Diseases Research	000	1	12/14/2020	NEW	$196,884
														Subtotal = $196,884

Grand Total All Awards = $981,842

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Early Respiratory Care in Amyotrophic Lateral Sclerosis Patients at High Risk for Respiratory Failure

Award Number: K23HL151879

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 01/01/2021

PERIOD OF PERFORMANCE END DATE: 06/30/2026

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